Route Maps

The Route Maps are designed to guide you through the legal and good practice requirements when designing conducting and disseminating experimental medicine studies.

Before using the Route Maps, take time to think about your project and its setting. Consider the following:

The research question and design of your study. In particular, would your study be classified as a clinical trial of an investigational medicinal product? Be aware that first time in human, small scale, proof of concept or safety studies of potential drug interventions (including gene therapy) will fall under the statutory definition of a clinical trial of an investigational medicinal product.

Where you are in the project. There are 3 main Route Maps and a number of sub maps covering different stages in a study. The key stages are identified as "stations." Click on a station and you will find helpful information and, where relevant, one or more "resources". Resources provide advice and links to other sites. Each station and each resource is categorised as best practice, legal requirement or standard process (see below).

The expertise of your research team and organisation. Some resources on this site are addressed to the needs of Researchers, others are of particular interest to Research Managers.

You can access the Route Maps in either Map view or in List view and you can download your chosen map in PDF format (you will need to do this in order to print the maps). You can select the List view at any stage; and you can download each map from the relevant Map page. You will need Acrobat Reader to read PDF documents (Acrobat Reader can be downloaded from the end of this page).

Experimental medicine has a broad definition and can encompass studies at all points through the transition from bench to patient and back. This Tool Kit is designed to support all such studies: it does so in combination with the Clinical Trials Toolkit and the MRC Data and Tissues Tool Kit, to which you will be directed whenever appropriate. Not all stations will be relevant for all studies; stations should be excluded on an informed basis.

The Tool Kit consists of:

Protocol Development

Step by step guidance on how to develop a research question into a protocol / proposal; with appropriate consideration of the risks to all those likely to be involved in the study and the implementation of appropriate strategies to minimise the risks posed.

Funding & Approvals

Guidance on the research approvals process including those areas that commonly require early consultation. Users are supported in identifying relevant statutory requirements, and are directed towards authoritative information resources that support compliance.

Study Management & Closure

Guidance on how to manage a study once all approvals are in place; with emphasis on the importance of continued risk assessment. Specific help is also given on the processes involved in amending protocols and closing a study, including appropriate dissemination strategies and data archiving.

Using the maps

Move along each map from left to right. That is the direction in which the processes flow.

Some processes can be done in parallel.

Not all stations will be relevant, it depends on the project. All information is provided so that you can exclude stations on an informed basis.

Click on a station and you will be taken to an introductory section on the topic, and a list of relevant resources (not all stations have resources). Some stations have a sub map.

To print the maps you will first need to download the PDF, this can be done from each Route Map page.

Station and resource categories

Each station and each resource is colour coded, to distinguish between legal requirements (red); good practice (blue); and standard processes (black). In some situations, good practice can be considered mandatory (e.g. by the NHS) although it does not have statutory force.

Specific information about the use of human tissue and data, or on the conduct of clinical trials of investigational medicinal products is available on the Data and Tissues Tool Kit and Clinical Trials Toolkit. Links are provided to relevant stations in these tool kits thought the EM Tool Kit.

List View

An alternative to the maps has been provided, called the List View, here the same information is displayed in a list. You can select the List View at any stage whilst using the route maps.

Other features

EM study scenarios are available to help illustrate how to implement best practice. These scenarios are a mixture of fictitious and real-life examples of EM studies, covering a range of interventions. Scenarios will be further developed using an iterative process.

Glossary of terms used on this tool kit and / or commonly used terms is available.

Documents

There are many documents available for download from this website. You will need to have Adobe Acrobat Reader installed on your machine to be able to read them.

This Tool Kit expands on the good practice outlined in Academy of Medical Sciences report 'Microbial challenge studies of human volunteers'. Where appropriate you will be directed to other Tool Kits.
More info.